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U.S. Department of Health and Human Services

Class 2 Device Recall G1 Dissection Tool

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  Class 2 Device Recall G1 Dissection Tool see related information
Date Initiated by Firm August 26, 2016
Create Date September 16, 2016
Recall Status1 Terminated 3 on November 29, 2017
Recall Number Z-2837-2016
Recall Event ID 75121
510(K)Number K113476  
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
Code Information Material L-7B-G1 Batch K043113667
Recalling Firm/
The Anspach Effort, Inc.
4500 Riverside Dr
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Jennifer Breston
Manufacturer Reason
for Recall
Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed.
FDA Determined
Cause 2
Device Design
Action On April 26, 2016 DePuy Synthes sent a letter informing their customers of the recall. ACTION REQUIRED Our records show that your facility has received one or more of product(s) subject to the recall (correction). The Anspach Effort, Inc. asks that you: 1) There is no requirement for retaining your inventory of Gl Dissection Tools. 2) To ensure Gl Cutting Tool & Attachment compatibility, please reference Table 1 to review which Attachments are compatible. The Cutting TooVAttachment combination noted with a check mark in Table I will function as intended. The Cutting Tool/Attachment combinations noted with an "X" in Table 1 will not secure effectively and should not be used. 3) Review, complete, sign and return the attached reply form confirming your receipt of this letter by fax or email details provided on the form. Returning the form promptly will prevent you from receiving repeat notices. 1. Share this letter with others in your facility that needs to be made aware of this recall (correction). 2. If you distribute any of the product(s) subject to the recall (correction) to other services or facilities, please forward this letter as appropriate immediately. 3. Keep a copy of this notice with the product(s) subject to the recall (correction). If you have any questions regarding this correction, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.
Quantity in Commerce 177
Distribution AZ, DC, CA, MD, MI, and OR Switzerland
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HBE and Original Applicant = THE ANSPACH EFFORT, INC.